Short-term Efficacy of a Single Ultrasound-guided Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis: a Randomized Controlled Double-blind Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in base-of-thumb pain 3 months post-injection
研究概览
简要总结
The primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis.
详细描述
Base-of-thumb osteoarthritis is a common condition affecting middle-age persons. Base-of-thumb osteoarthritis induces pain and hand-specific limitations in activities. For short and midterm effects, therapeutic options usually include splinting, exercise therapy and intra-articular injections of glucocorticoids or hyaluronic acid. However, evidence of efficacy of intra-articular therapies in base-of-thumb osteoarthritis and international guidelines are inconsistent. Recently, the use of intra-articular botulinum toxin A as a pain killer has raised intense interest. The exact mechanisms of pain modulation by botulinum toxin A in osteoarthritis are unclear. It has been suggested that botulinum toxin A could directly reduce peripheral sensitization and indirectly reduce central sensitization. Indeed, recent studies suggest an inhibitory role of botulinum toxin A on the release of mediators involved in nociception, such as P substance, calcitonin gene-related peptide and glutamate. Open and randomized controlled trials of botulinum toxin A in knee osteoarthritis support short to mid-term positive clinical effects on pain. However, no study has reported results for base-of-thumb osteoarthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
- •Pain involving the base-of-thumb
- •X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts
- •1990 American College of Rheumatology classification criteria for hand osteoarthritis adapted to base-of-thumb osteoarthritis
- •Medical examination
- •Written consent
- •Health insurance
- •For women of childbearing age, a negative urinary pregnancy test
排除标准
- •History of thumb surgery
- •History of inflammatory or crystal-associated rheumatic disease
- •Neurological disorders involving the hands other than carpien canal syndrom
- •Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
- •Osteoarthritis predominating at the scaphotrapezial joint on X-Ray
- •Hand or wrist trauma ≤ 2 months
- •Hand or wrist intra-articular injections ≤ 2 months
- •Contra-indication to botulinum toxin A injection or to splinting
- •Cognitive or behavioral disorders making the assessment impossible
- •Participant unable to speak, read and write french
- •Bilateral BTOA without predominant symptomatic side
- •Pregnancy and breast feeding
- •Persons referred to in Articles L 1121-5; 6; 8; 9 of the Public Health Code (protected minors or adults, guardianship or trusteeship, etc.)
- •Patient with epilepsy
研究组 & 干预措施
Intra-articular botulinum toxin A and splinting
Ultrasound-guided injection of 50 Allergan Unities of botulinum toxin A (Botox®, Allergan) resuspended in 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly
干预措施: botulinum toxin A (Drug)
Intra-articular saline and splinting
Ultrasound-guided injection of 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly
干预措施: saline (Drug)
结局指标
主要结局
Change in base-of-thumb pain 3 months post-injection
时间窗: 3 months post injection
Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain)
次要结局
- Change in patient's global assessment 3 months post-injection(3 months post-injection)
- Percentage of OARSI responders 3 months post-injection(3 months post-injection)
- Change in base-of-thumb pain 6 months post-injection(6 months post injection)
- Percentage of OARSI responders 6 months post-injection(6 months post-injection)
- Non-steroidal anti-inflammatory drugs consumption at 3 months(from injection to 3 months post-injection)
- Non-steroidal anti-inflammatory drugs consumption at 6 months(from 3 to 6 months post-injection)
- Change in base-of-thumb pain 1 month post-injection(1 month post injection)
- Change in hand function 3 months post-injection(3 months post injection)
- Change in hand function 6 months post-injection(6 months post injection)
- Change in patient's global assessment 6 months post-injection(6 months post-injection)
- Analgesics consumption at 6 months(from 3 to 6 months post-injection)
- Analgesics consumption at 3 months(from injection to 3 months post-injection)